Respiratory device for providing bubble CPAP

Abstract

A respiratory system with a flow generator can provide bubble CPAP therapy by controlling a pressure of a flow of gas delivered to a patient. A controller of the respiratory system can control a motor speed of its flow generator in order to control the pressure of the flow of gas. The controller can also detect the presence of bubbling and / or possible leaks in a gas path of the system. The respiratory system can include a high flow respiratory system.

Description

[0001] This application is a divisional application of Chinese Patent Application No. 202080022190.0, filed on December 10, 2021, entitled “Breathing Device for Providing Bubble CPAP”, the contents of which are incorporated herein by reference. Technical Field

[0002] This disclosure relates to methods and systems for providing respiratory flow therapy to patients. In particular, it relates to the use of flow generators to provide bubble CPAP therapy. Background Technology

[0003] Ventilation assist devices are used in a variety of environments, such as hospitals, medical facilities, residential care, or home environments, to deliver airflow to users or patients. Ventilation assist or respiratory therapy devices (collectively referred to as "respiratory equipment" or "breathing apparatus") can be used to deliver supplemental oxygen or other gases via airflow, and / or humidification devices can be used to deliver heated and humidified gases. Breathing equipment allows for the adjustment and control of airflow characteristics, including flow rate, temperature, gas concentration, humidity, and pressure. Sensors such as flow sensors and / or pressure sensors are used to measure these airflow characteristics. Summary of the Invention

[0004] Bubble Continuous Positive Airway Pressure (CPAP) is a form of respiratory therapy in which an airflow is supplied to a patient (typically an infant) via a patient interface. The airflow is typically provided by a gas source within the walls of a hospital or clinic, or may be provided by cylinders of compressed air and / or oxygen, for example, during transport. The patient interface connects to two tubing lines: an inspiratory tubing and an expiratory tubing. The inspiratory tubing delivers gas to the patient. The expiratory tubing provides a pathway for the gas exhaled by the patient. The expiratory tubing communicates with a pressure regulator used to set the pressure. The pressure regulator may be a chamber containing a column of water, with the distal portion of the expiratory tubing submerged in the water column. Exhaled gas is released into the pressure regulator. The release of exhaled gas into the water causes the water to bubble, i.e., the bubbling effect. The patient interface is typically configured to form a seal with the patient's mouth and / or nose. Examples of a sealed patient interface may include a nasal mask, a face mask, a full-face mask, a nasal pillow, or a cannula with a sealed nasal plug.

[0005] In some locations, such as certain developing countries or remote areas, wall-mounted sources may not be available. This disclosure provides systems and methods for providing bubble CPAP therapy using flow generators as alternatives to wall-mounted sources and / or optionally in addition to wall-mounted sources. The flow generator may also include an integrated humidifier to heat and humidify the airflow. An example of a flow generator with an integrated humidifier is a high-flow-rate breathing apparatus. Heated ventilation tubing may also be used with high-flow-rate breathing apparatus to deliver airflow from the humidifier to the patient interface. The flow generator may also include an integrated mixer to provide supplemental gas to the airflow. The flow generator is preferably a flow generator that draws in an ambient gas, such as ambient air, rather than being connected to a gas source such as a gas tank or wall-mounted source. The mixer allows one or more supplemental gases to be mixed with the drawn-in ambient gas.

[0006] High-flow ventilators can provide a variety of treatment modes, including but not limited to high-flow therapy (also known as nasal high-flow therapy or tracheal high-flow therapy), CPAP, bilevel and bubble CPAP, so that patients do not need to switch to different ventilators when switching to different ventilator modes (e.g., when the patient’s condition changes).

[0007] High-flow ventilator can operate in bubble CPAP therapy mode or nasal high-flow therapy mode (described in more detail below). Alternatively, the high-flow ventilator can also operate in other high-flow therapy modes, such as tracheal high-flow or other high-flow modes. Nasal high-flow is delivered via a nasal interface. Tracheal high-flow can be delivered via a tracheal interface. Other interfaces are also possible, such as an oral interface that delivers high flow to the airway via an oral passage. The described ventilator can operate in high-flow therapy mode or bubble CPAP mode.

[0008] High-flow nasal breathing devices operate as flow control devices, as described in more detail below (e.g., a high-flow nasal breathing device can control the blower motor to achieve a target flow rate). The target flow rate can be a constant flow rate. The target flow rate can be set by the user or based on whether the device is in bubble CPAP therapy mode or nasal high-flow therapy mode. In one example, the controller can contain predefined target flow rates for both bubble CPAP therapy mode and nasal high-flow therapy mode. The predefined target flow rates can be stored in the controller's memory.

[0009] When operating in bubble CPAP mode, high-flow-rate breathing devices can control the motor speed of their flow generator, which can be a blower, to deliver a constant flow rate (including a substantially constant flow rate). The device can monitor pressure in the ventilation circuit (also known as the ventilation tubing or inspiratory tubing) or the device's flow path and can adjust the target motor speed if the pressure exceeds a limit. The device can also replace the pressure relief valve in a conventional bubble CPAP system with software control to provide better control over airflow pressure. The device can provide a variety of alarms and monitoring. For example, the device can determine the presence of irregular amounts of leakage, blockage, intermittent bubbling, suggested and / or automatic flow rate changes, flow rates that do not meet inspiratory needs (if pressure exceeds a threshold), and / or detect the presence of bubbling. High-flow-rate breathing devices can further limit the pressure delivered to the patient so that the pressure is below a pressure limit. In one example, in bubble CPAP mode, the flow rate can be a high flow rate.

[0010] The terms respiratory equipment and respiratory apparatus can be used interchangeably to describe and define the same item.

[0011] A breathing device or apparatus may be part of a breathing system that includes one or more additional components (e.g., an inspiratory tube, an expiratory tube, a bubbler) as described in more detail below.

[0012] In some configurations, a respiratory device configured to deliver respiratory therapy to a patient via a patient interface may include: a controller; a blower including a motor, wherein the motor speed of the blower can be controlled by the controller; a pressure sensor configured to measure the pressure of airflow downstream of the blower; wherein the controller may be configured to: compare the pressure with a threshold; reduce the target motor speed of the blower in response to the pressure exceeding the threshold; and control the motor speed to achieve a target flow rate in response to the pressure not exceeding the threshold.

[0013] In some configurations, a respiratory device configured to deliver respiratory therapy to a patient via a patient interface may include: a controller; a blower including a motor, wherein the motor speed of the blower is controlled by the controller to a target motor speed; a pressure sensor configured to measure the pressure of an airflow downstream of the blower; wherein the controller is configured to: compare the pressure with a threshold; reduce the target motor speed of the blower in response to the pressure exceeding the threshold; and adjust the target motor speed to achieve a target flow rate in response to the pressure not exceeding the threshold.

[0014] In some configurations, a respiratory device configured to deliver respiratory therapy to a patient via a patient interface may include: a controller; a blower, wherein the blower is controlled by the controller; a pressure sensor configured to measure the pressure of an airflow downstream of the blower; wherein the controller is configured to: compare the pressure with a threshold; if the pressure exceeds the pressure threshold, control the blower to reduce the pressure below the threshold; and if the pressure does not exceed the threshold, control the blower to achieve a target flow rate.

[0015] In some configurations, the blower includes a motor.

[0016] In some configurations, the blower is controlled by adjusting one or more of the motor speed, motor current, and / or motor voltage to a target motor speed, target motor current, and / or target motor voltage.

[0017] In some configurations, the target motor speed can decrease at a constant rate. In other configurations, the target motor speed can decrease at a variable rate.

[0018] In some configurations, the controller can be configured to continuously reduce the target motor speed until the pressure is below a threshold.

[0019] In some configurations, the pressure sensor can be an absolute pressure sensor.

[0020] In some configurations, pressure can be measured by obtaining the difference between the reading of the pressure sensor and the reading of a second pressure sensor, both of which are absolute pressure sensors.

[0021] In some configurations, the pressure sensor can be a gauge pressure sensor configured to acquire the difference between ambient pressure and the pressure downstream of the blower.

[0022] In some configurations, the controller can be configured to receive input of the target flow rate.

[0023] In some configurations, the target flow rate can be set by the user.

[0024] In some configurations, the device may include an oxygen inlet separate from the ambient inlet.

[0025] In some configurations, the blower can be configured to mix ambient air from the ambient air inlet with oxygen from the oxygen inlet.

[0026] In some configurations, FdO2 can be partially dependent on the target flow rate.

[0027] In some configurations, the controller can be further configured to control FdO2 by controlling the opening of the oxygen inlet valve.

[0028] In some configurations, the target flow rate can be constant.

[0029] In some configurations, the device can be connected to a bubbler, and the controller can be configured to detect foaming by monitoring changes in flow parameter signals.

[0030] In some configurations, flow parameter signals may include flow rate signals, pressure signals, or combinations thereof.

[0031] In some configurations, the variation can be the change in the amplitude of the stream parameter signal relative to a threshold.

[0032] In some configurations, the changes can be analyzed in the frequency domain.

[0033] In some configurations, the controller can be configured to output a warning in response to the absence of bubbling within a predetermined time period.

[0034] In some configurations, the controller can be configured to output one or more of the following warnings based on whether foaming is detected: leakage, blockage, intermittent foaming, suggested and / or automatic flow rate changes, and / or flow rate not meeting inhalation requirements.

[0035] In some configurations, the device may further include a humidification chamber.

[0036] In some configurations, the device may further include one or more flow rate sensors.

[0037] In some configurations, the device can be a high-flow breathing device.

[0038] In some configurations, the system includes a battery.

[0039] In some configurations, the battery serves as the main power source for the device.

[0040] In some configurations, the battery serves as an auxiliary power source for the device.

[0041] In some configurations, the device includes a motor speed limiter.

[0042] In some configurations, motor speed limits are based on environmental pressure.

[0043] In some configurations, the system may include any configuration of the devices described above. The system may further include an inspiratory conduit for providing airflow to the patient interface.

[0044] In some configurations, the patient interface can form a seal on or around the patient's face.

[0045] In some configurations, the patient interface can be configured to connect to the expiratory tubing.

[0046] In some configurations, the exhalation tubing can be configured to connect to the bubbler.

[0047] In some configurations, the system may not include a pressure reducing valve between the blower and the patient interface.

[0048] In some configurations, a method of providing bubble CPAP via a patient interface coupled to a breathing apparatus including a flow generator comprising a motor electrically communicating with a controller of the breathing apparatus may include: measuring the pressure of an airflow downstream of the flow generator based on readings from a pressure sensor; comparing the pressure to a threshold; reducing a target motor speed of the flow generator in response to the pressure exceeding the threshold; and controlling the motor speed to achieve a target flow rate in response to the pressure not exceeding the threshold.

[0049] In some configurations, a method of providing bubble CPAP via a patient interface coupled to a breathing apparatus including a flow generator comprising a motor electrically communicating with a controller of the breathing apparatus configured to control the motor to a target motor speed may include: measuring the pressure of an airflow downstream of the flow generator based on readings from a pressure sensor; comparing the pressure to a threshold; reducing the target motor speed of the flow generator in response to the pressure exceeding the threshold; and adjusting the target motor speed to achieve a target flow rate in response to the pressure not exceeding the threshold.

[0050] In some configurations, a method of providing bubble CPAP via a patient interface coupled to a breathing apparatus including a flow generator comprising a blower electrically communicating with a controller of the breathing apparatus, the blower optionally including a motor, the controller being configured to control the motor to a target motor speed, the method may include: measuring the pressure of the airflow downstream of the flow generator based on readings from a pressure sensor; comparing the pressure to a threshold; if the pressure exceeds the pressure threshold, controlling the blower to reduce the pressure below the threshold; and if the pressure does not exceed the threshold, controlling the blower to achieve a target flow rate.

[0051] In some configurations, the blower is controlled by adjusting one or more of the motor speed, motor current, and / or motor voltage to a target motor speed, target motor current, and / or target motor voltage.

[0052] In some configurations, the target motor speed can decrease at a constant rate. In other configurations, the target motor speed can decrease at a variable rate.

[0053] In some configurations, the method may involve continuously reducing the target motor speed until the pressure is below a threshold.

[0054] In some configurations, the pressure sensor can be an absolute pressure sensor.

[0055] In some configurations, the measurement may include obtaining the difference between the reading of the pressure sensor and the reading of a second pressure sensor, both of which are absolute pressure sensors.

[0056] In some configurations, the pressure sensor can be a gauge pressure sensor configured to acquire the difference between ambient pressure and the pressure downstream of the flow generator.

[0057] In some configurations, the target flow rate can be constant.

[0058] In some configurations, the method may include receiving input of the target flow rate.

[0059] In some configurations, the target flow rate can be set by the user.

[0060] In some configurations, control may include running a PID controller based on the difference between the target flow rate and the flow rate delivered to the patient, as measured by one or more flow rate sensors, to determine the desired motor speed.

[0061] In some configurations, the device may include an oxygen inlet separate from the ambient inlet.

[0062] In some configurations, the flow generator can be configured to mix ambient air from the ambient air inlet with oxygen from the oxygen inlet.

[0063] In some configurations, FdO2 can be partially dependent on the target flow rate.

[0064] In some configurations, the method may further include controlling FdO2 by controlling the opening of the oxygen inlet valve.

[0065] In some configurations, the method may further include detecting bubbles in a bubbler connected to the breathing apparatus by monitoring changes in flow parameter signals.

[0066] In some configurations, flow parameter signals may include flow rate signals, pressure signals, or combinations thereof.

[0067] In some configurations, the variation can be the change in the amplitude of the stream parameter signal relative to a threshold.

[0068] In some configurations, the changes can be analyzed in the frequency domain.

[0069] In some configurations, the method may further include outputting a warning in response to the absence of bubbling within a predetermined time period.

[0070] In some configurations, the method may further include outputting one or more of the following warnings based on whether foaming is detected: leakage, blockage, intermittent foaming, suggested and / or automatic flow rate changes, and / or flow rate not meeting inhalation requirements.

[0071] In some configurations, the device may further include a humidification chamber.

[0072] In some configurations, the device includes a battery.

[0073] In some configurations, the battery serves as the main power source for the device.

[0074] In some configurations, the battery serves as an auxiliary power source for the device.

[0075] In some configurations, the device includes a motor speed limiter.

[0076] In some configurations, motor speed limits are based on environmental pressure.

[0077] In some configurations, the device may be included in a respiratory system that includes a patient interface, wherein the system does not include a pressure reducing valve between the flow generator and the patient interface.

[0078] In some configurations, the breathing device can be connected to an inspiratory tubing that delivers airflow to the patient interface.

[0079] In some configurations, the patient interface can form a seal on or around the patient's face.

[0080] In some configurations, the patient interface can be configured to connect to the expiratory tubing.

[0081] In some configurations, the exhalation tubing can be configured to connect to the bubbler.

[0082] In some configurations, a respiratory system configured to deliver bubble CPAP therapy to a patient via a patient interface may include: a respiratory device comprising: a controller; a blower including a motor, wherein the motor speed of the blower can be controlled by the controller, the blower being configured to generate airflow to the patient at a target flow rate; and a housing enclosing the controller and the blower; an inspiratory conduit for providing airflow to the patient interface; and an expiratory conduit having a proximal end coupled to the patient interface, and the distal end being immersed to a predetermined depth of the water column.

[0083] In some configurations, the system can be further configured as a pressure sensor that measures the pressure of the airflow downstream of the blower, wherein the controller can be configured to: compare the pressure with a threshold; reduce the target motor speed of the blower in response to the pressure exceeding the threshold; and control the motor speed to achieve the target flow rate in response to the pressure not exceeding the threshold.

[0084] In some configurations, a respiratory system configured to deliver bubble CPAP therapy to a patient via a patient interface may include: a respiratory device comprising: a controller; a blower including a motor, wherein the motor speed of the blower can be controlled by the controller to a target motor speed, the blower being configured to generate airflow to the patient at a target flow rate; and a housing enclosing the controller and the blower; an inspiratory conduit for providing airflow to the patient interface; and an expiratory conduit having a proximal end coupled to the patient interface and the distal end immersed to a predetermined depth of the water column.

[0085] The blower includes an inlet for drawing in ambient air and driving it to the patient via a patient tubing (i.e., an inhalation tubing). A controller directs the blower to a target motor speed or a target flow rate, or both. The controller preferably provides a control signal to control the current, voltage, or electrical power supplied to the motor of the blower, i.e., to vary the current, voltage, or electrical power to achieve the target motor speed or target flow rate. The respiratory system may also optionally include a supplemental gas inlet to receive a supplemental gas, such as oxygen. The blower is configured to receive ambient gas and supplemental gas and mix these gases together.

[0086] In some configurations, the system can be further configured as a pressure sensor to measure the pressure of the airflow downstream of the blower, wherein the controller can be configured to: compare the pressure with a threshold; reduce the target motor speed of the blower in response to the pressure exceeding the threshold; and adjust the target motor speed to achieve a target flow rate in response to the pressure not exceeding the threshold.

[0087] In some configurations, the system can be further configured as a pressure sensor to measure the pressure of the airflow downstream of the blower, wherein the controller can be configured to: compare the pressure with a threshold; if the pressure exceeds the pressure threshold, control the blower to reduce the pressure below the threshold; and if the pressure does not exceed the threshold, control the blower to achieve a target flow rate.

[0088] In some configurations, the blower is controlled by adjusting one or more of the motor speed, motor current, and / or motor voltage to a target motor speed, target motor current, and / or target motor voltage.

[0089] In some configurations, the target motor speed can decrease at a constant rate. In other configurations, the target motor speed can decrease at a variable rate.

[0090] In some configurations, the controller can be configured to continuously reduce the target motor speed until the pressure is below a threshold.

[0091] In some configurations, the pressure sensor can be an absolute pressure sensor.

[0092] In some configurations, pressure can be measured by obtaining the difference between the reading of the pressure sensor and the reading of a second pressure sensor, both of which are absolute pressure sensors.

[0093] In some configurations, the pressure sensor can be a gauge pressure sensor configured to acquire the difference between ambient pressure and the pressure downstream of the blower.

[0094] In some configurations, the target flow rate can be constant.

[0095] In some configurations, the controller can be configured to receive input of the target flow rate.

[0096] In some configurations, the target flow rate can be set by the user.

[0097] In some configurations, the device may include an oxygen inlet separate from the ambient inlet.

[0098] In some configurations, the blower can be configured to mix ambient air from the ambient air inlet with oxygen from the oxygen inlet.

[0099] In some configurations, FdO2 can be partially dependent on the target flow rate.

[0100] In some configurations, the controller can be further configured to control FdO2 by controlling the opening of the oxygen inlet valve.

[0101] In some configurations, the system may include an aerator in which a water column is contained.

[0102] In some configurations, the controller can be configured to detect bubbling by monitoring changes in flow parameter signals.

[0103] In some configurations, flow parameter signals may include flow rate signals, pressure signals, or combinations thereof.

[0104] In some configurations, the variation can be the change in the amplitude of the stream parameter signal relative to a threshold.

[0105] In some configurations, the changes can be analyzed in the frequency domain.

[0106] In some configurations, the controller can be configured to output a warning in response to the absence of bubbling within a predetermined time period.

[0107] In some configurations, the controller can be configured to output one or more of the following warnings based on whether foaming is detected: leakage, blockage, intermittent foaming, suggested and / or automatic flow rate changes, and / or flow rate not meeting inhalation requirements.

[0108] In some configurations, the patient interface can form a seal on or around the patient's face.

[0109] In some configurations, the device may further include a humidification chamber.

[0110] In some configurations, the device may further include one or more flow rate sensors.

[0111] In some configurations, the system may not include a pressure reducing valve between the blower and the patient interface.

[0112] In some configurations, the device can be a high-flow breathing device.

[0113] In some configurations, the device includes a battery.

[0114] In some configurations, the battery serves as the main power source for the device.

[0115] In some configurations, the battery serves as an auxiliary power source for the device.

[0116] In some configurations, the device includes a motor speed limiter.

[0117] In some configurations, motor speed limits are based on environmental pressure.

[0118] In some configurations, a respiratory system configured to deliver high-flow therapy or bubble CPAP therapy includes: a breathing device including a flow generator; a humidifier in fluid communication with the flow generator; a controller for electronically controlling the flow generator; and an inhalation tubing in fluid communication with the humidifier. The breathing device is switchable between a high-flow therapy mode and a bubble CPAP therapy mode, wherein in the high-flow therapy mode, the breathing device is configured to provide high-flow therapy, and in the bubble CPAP therapy mode, the breathing device is configured to provide bubble CPAP therapy.

[0119] In some configurations, high-flow treatment is referred to as nasal high-flow treatment.

[0120] In some configurations, the breathing apparatus includes a housing, a flow generator, and a humidifier integrated into the housing. A controller is also located within the housing. The humidifier may include a heater plate and a humidification chamber. The heater plate is located within the housing. The housing defines a chamber compartment, and the heater plate is located within the chamber compartment. The humidification chamber is removably positioned on the heater plate. The housing includes a gas outlet, and an inhalation tube is connectable to the outlet.

[0121] In high-flow treatment mode, the system includes an unsealed patient interface connected to the inspiratory tubing.

[0122] In high-flow treatment mode, the system includes an unsealed patient interface connected to the inspiratory tubing.

[0123] In some configurations, the unsealed patient interface can be a nasal cannula.

[0124] In some configurations, during use, the nasal cannula is positioned on the user's face to deliver air to the user's nostrils.

[0125] In the bubble CPAP therapy mode, the system includes a sealed patient interface connected to an inspiratory conduit, an expiratory conduit connected to the sealed patient interface, and wherein the expiratory conduit is connected to a pressure regulator to regulate the pressure within the patient interface and / or the patient's airway.

[0126] In some configurations, the pressure regulator includes a chamber with a water column, and the exhalation tubing is submerged in the water column. The pressure supplied to the user is defined or set by the depth to which the exhalation tubing is submerged in the water column.

[0127] In some configurations, the inhalation tubing is shared between high-flow treatment mode and bubble CPAP treatment mode.

[0128] In some configurations, the controller includes a high-flow treatment control program associated with the high-flow treatment mode.

[0129] In some configurations, the controller includes a bubble CPAP treatment control program associated with the bubble CPAP treatment mode.

[0130] In some configurations, the controller is configured to select and apply a program corresponding to the selected operating mode.

[0131] In some configurations, each program defines its own operating parameters.

[0132] In some configurations, operating parameters may include one or more motor speeds or pressure limits (e.g., pressure upper limit).

[0133] In some configurations, the operating parameters may include one or more alarm conditions.

[0134] In some configurations, one or more alarm conditions may be included in the absence of bubbling in the bubble CPAP treatment mode.

[0135] In some configurations, the operating parameters can define the humidity level.

[0136] In some configurations, the operating parameters can be one or more temperature or dew point setpoints to control the humidifier.

[0137] In some configurations, the humidity level provided during high-flow mode can be greater than the humidity level provided during bubble CPAP therapy mode.

[0138] In some configurations, the operating parameters can also define the traffic limits for each mode.

[0139] In some configurations, the controller is configured to detect foaming by the bubbler, and if foaming is detected, the controller selects the bubble CPAP treatment mode.

[0140] In some configurations, if a bubbler is detected by bubbling, the controller can automatically switch modes.

[0141] In some configurations, users can choose between a high-flow treatment mode or a bubble CPAP treatment mode (optionally via the user interface).

[0142] In some configurations, the controller is configured to detect bubbling by monitoring changes in flow parameter signals.

[0143] In some configurations, flow parameter signals include flow rate signals, pressure signals, or combinations thereof.

[0144] In some configurations, the variation is the change in the amplitude of the stream parameter signal relative to a threshold.

[0145] In some configurations, the changes are analyzed in the frequency domain.

[0146] In some configurations, the same inhalation conduit can be used for both bubble CPAP and high-flow modes. Using the same inhalation conduit for both modes reduces the number of components that need to be interchanged when changing modes. Furthermore, this common inhalation conduit allows the same breathing device, including a blower and humidifier integrated into the housing, to be used for both bubble CPAP and high-flow modes. Additionally, integrating the humidifier and blower into a common housing simplifies switching between bubble CPAP and high-flow modes because a single device can be used, rather than a single setup of several components as required in prior art systems. The system of this invention provides a single breathing device that can be used to deliver both bubble CPAP and high-flow therapy, with only the interface requiring a change. There are no changes to the components on the gas supply side; that is, the gas supply components remain unchanged because the common breathing device can be used to deliver humidified gas.

[0147] In some configurations, the high-flow therapy mode kit used with the breathing device includes one or more of the following: an unsealed patient interface and an inspiratory tubing.

[0148] In some configurations, the high-flow treatment mode kit is used in high-flow treatment mode (as described elsewhere in this specification).

[0149] In some configurations, the bubble CPAP therapy mode kit used with the breathing device includes one or more of the following: a sealed patient interface, an inspiratory tubing, an expiratory tubing, and / or a bubbler.

[0150] In some configurations, the bubble CPAP treatment mode kit is used in bubble CPAP treatment mode (as described elsewhere in this manual). Attached Figure Description

[0151] These and other features, aspects, and advantages of this disclosure are described with reference to the accompanying drawings of certain embodiments, which are intended to illustrate certain embodiments and are not intended to limit the scope of this disclosure.

[0152] Figure 1 schematically illustrates the standard setup for using a breathing device to provide bubble CPAP.

[0153] Figure 2 A schematic illustration of a breathing apparatus with a flow generator for providing bubble CPAP.

[0154] Figure 3A This illustration depicts a high-flow respiratory system configured to provide respiratory therapy to a patient.

[0155] Figure 3B A front perspective view of an example high-flow breathing device with a humidification chamber in the proper position.

[0156] Figure 3C for Figure 3B Rear perspective view of the breathing equipment.

[0157] Figure 4 illustrate Figure 3B An example of a sensing chamber in a breathing device.

[0158] Figure 5 This diagram illustrates an example block diagram of motor control in a breathing apparatus with a flow generator that provides bubble CPAP.

[0159] Figure 6 This illustrates an example flowchart for detecting bubbling when providing bubble CPAP.

[0160] Figure 7 This describes a respiratory device with a high-flow therapy controller program and a bubble CPAP therapy controller program. Detailed Implementation

[0161] While certain examples are described below, those skilled in the art will understand that this disclosure extends beyond the specific examples and / or uses disclosed herein, as well as their obvious modifications and equivalents. Therefore, it is expected that the scope of this disclosure as described herein should not be limited by any particular examples described below.

[0162] Bubble CPAP therapy can cause changes or oscillations in the pressure of the gas supplied to a patient connected to a positive pressure ventilation device. By immersing one end of the expiratory tubing in a column of water, the resulting bubbles cause changes or fluctuations in the pressure of the gas delivered to the patient. Bubble CPAP systems also provide a method for varying the mean pressure of the gas supplied to the patient by changing the level of the liquid level at the end of the expiratory tubing within the water column. The immersion level at the end of the expiratory tubing can be kept constant to maintain the mean pressure of the gas supplied to the patient.

[0163] As shown in Figure 1, a conventional respiratory system for providing bubble CPAP therapy can supply humidified and pressurized gas to a patient 119 via a patient interface, such as a hood 128 connected to an inspiratory conduit 121 in Figure 1. The inspiratory conduit 121 is connected to an outlet 112 of a humidification chamber 110 containing a volume of water 115. When the volume of water 115 within the humidification chamber 110 is heated by a heater plate 113 in the device housing 114, water vapor begins to fill the volume of the chamber 110 above the water surface. The water vapor can be heated and humidified from a wall source 118 (see Figure 1) via an inlet 116 to the airflow (e.g., air) within the chamber 110. The heated and humidified gas exits from the outlet 112 of the humidification chamber 110 into the inspiratory conduit 121. The intake duct 121 may house a heater, such as heating wire 120 in FIG. 1, which heats the walls of the duct to promote a substantially constant humidity profile along the intake duct 121 and thus reduce condensation of the humidified gas within the intake duct 121. The device may be powered, for example via input from one or more sensors in the system, to heat the intake duct 121 and the heater plate 113, as will be described in further detail below.

[0164] Humidified gas can be delivered through inhalation conduit 121 to a patient interface, such as mask 128, attached to or sealed around the mouth, nose, and / or nostrils of patient 119. Inhalation conduit 121 provides an airflow to patient 119, which can be ambient air, oxygen, a mixture of both, or a mixture of ambient air and other auxiliary gases. The gas may contain medication that can be added via nebulization. In bubble CPAP, the airflow through inhalation conduit 121 can be delivered at a substantially constant flow rate. As shown in Figure 1, an airflow supplied by a wall source 118 is provided. The wall source 118 can deliver gas at a target flow rate to maintain the flow rate of gas delivered to the patient.

[0165] As shown in Figure 1, excess gas can flow through the exhalation tubing 130 to a pressure regulator 134, which in this illustrated example is an evaporator. In a bubble CPAP system, the exhalation tubing 130 can terminate at an open terminal 136. This terminal 136 can be immersed in a volume of water 138 inside the evaporator 134.

[0166] The bubbler can regulate pressure via a terminal 136 of the expiratory tubing 130, which is submerged in a volume of water 138 at a desired depth below water level 140. Terminal 136 may also optionally be located on a short tube that can be integrated into the end of the expiratory tubing 130. Whenever the pressure exceeds a desired level, the bubbler can act as a pressure regulator by expelling gas to maintain the mean or average pressure at the target level. The bubble CPAP system may also include a pressure relief valve 146 for expelling excess gas when the pressure exceeds the desired level. The bubbler can also provide pressure oscillations, which may have clinical benefits. Compared to intubation and / or mechanical ventilation, bubble CPAP therapy can reduce the incidence of acute lung injury and bronchopulmonary dysplasia.

[0167] Overview of Example Flow Therapy Devices

[0168] Figure 2 This describes an example respiratory device configured to provide bubble CPAP, having a flow generator 218 (also referred to as a blower, but may include other types of flow generators disclosed herein). Using a flow generator to produce airflow allows the respiratory device to provide bubble CPAP in situations where a wall source is unavailable, such as when a wall source is not possible. Additionally, using a flow generator, such as a blower, in a respiratory device allows the device to draw in ambient air and provide ambient air as the airflow for bubble CPAP. This allows the respiratory device to be simpler and cheaper to use because it eliminates the need for a gas reservoir or a gas source, such as a wall source. Furthermore, a respiratory device with a flow generator, such as a blower, is advantageous because there is no risk of gas depletion due to the provision of ambient air to the patient. This ensures that treatment is not interrupted due to an empty gas source, as the ambient air is sufficient. This is achieved by integrating a humidifier and optionally a supplemental gas mixer (e.g., by integrating...). Figure 3CThe oxygen inlet port 358' shown leads to the flow generator, requiring fewer separate components in the system, which simplifies its setup. Additionally, because there are fewer separate components connected by tubing, the system occupies less space. The described breathing device, with an integrated humidifier and optionally an integrated supplemental gas mixer, can occupy less space and reduce additional interconnecting tubing. Furthermore, the flow generator, integrated humidifier, and supplemental gas mixer can be controlled by a single controller, which allows for additional monitoring and control of various flow parameters, as further described. Additionally, the breathing device incorporating the flow generator can be able to provide other forms of therapy, such as high-flow nasal cannula therapy, thereby making it easier to switch between different types of respiratory support as the patient's condition changes, and can also reduce the number of consumable components required; for example, a common heated ventilation tubing can be used across multiple therapies, requiring only a change in the patient interface.

[0169] Figure 2 The respiratory system in this device may differ from the conventional bubble CPAP setup in Figure 1, at least in that airflow is provided by a blower 218 integrated within the device housing 214. Figure 2 The system may optionally include a supplemental gas source (such as an oxygen tank, an oxygen mixer connected to a flow meter, etc.) that controls the oxygen concentration in the gas flow delivered to the patient 119. The supplemental gas source may be connected to the device housing 214 and / or the blower 218 (e.g., at the supplemental gas inlet). The supplemental gas source may also be configured to provide other types of auxiliary gases, such as nitrogen. The supplemental gas source may be connected to an internal mixer that mixes ambient air with the supplemental gas to provide the gas flow to the patient. The concentration of the supplemental gas introduced into or present in the gas flow can be controlled. The system may include a temperature sensor, such as the temperature sensor 144 of FIG. 1, in the inhalation conduit 121. The temperature sensor 144 may be coupled to and in electrical communication with a controller located in the device housing 214.

[0170] In some embodiments, the blower is configured to receive ambient gas and makeup gas and mix these gases together.

[0171] Figure 2 The respiratory system in the body can include high-flow systems. Figure 3AA schematic representation of a high-flow-rate system 10 is provided. The respiratory system 10 may include a main housing 100. The main housing 100 may house a flow generator 11, which may be in the form of a motor / impeller arrangement (e.g., a blower); an optional humidifier or humidification chamber 12; a controller 13; and a user interface 14. The user interface 14 may include a display and input devices such as buttons, a touchscreen, a combination of touchscreen and buttons, etc. The controller 13 may include one or more hardware and / or software processors and may be configured or programmed to control components of the device, including, but not limited to, operating the flow generator 11 to generate an airflow for delivery to a patient, operating the humidifier 12 (if present) to humidify and / or heat the airflow, receiving user input from the user interface 14 for reconfiguration and / or user-defined operation of the respiratory system 10, and outputting information (e.g., on a display) to a user. The user may be a patient, a healthcare professional, or someone else.

[0172] Continue to refer to Figure 3A The patient ventilation tubing 16 can be connected to the airflow outlet 21 in the main housing 100 of the respiratory system 10 and to the patient interface 17. The patient interface can be a non-sealed interface, such as a nasal cannula with a manifold 19 and a nasal plug 18, for providing high-flow therapy. The nasal cannula does not completely seal against the user's nostrils, allowing exhaled air to leak around the nasal plug when the user exhales. The patient ventilation tubing 16 can also be connected to a sealed interface, such as a face mask, oronasal mask, nasal mask, nasal pillow mask, or nasal cannula, for providing bubble CPAP. The patient interface may also optionally include an endotracheal tube, a tracheostomy interface, or other interfaces.

[0173] The airflow can be generated by the flow generator 11 and can be humidified before being delivered to the patient via the patient interface 17 through the patient conduit 16. The controller 13 can control the flow generator 11 to generate an airflow with a desired flow rate and / or control one or more valves to control the mixing of air with oxygen or other inhalable gases. The controller 13 can control a heating element in the humidification chamber 12 (if present) to heat the gas to a desired temperature and / or humidity level for delivery to the patient. The patient conduit 16 may have a heating element 16a, such as a heating wire, to heat the airflow delivered to the patient. The heating element 16a may also be under the control of the controller 13. The heating element 16a heats the gas to reduce and / or prevent condensation within the patient conduit 16.

[0174] System 10 can use an ultrasonic transducer, a flow sensor such as a thermistor flow sensor, a pressure sensor, a temperature sensor, a humidity sensor, or other sensors that communicate with controller 13 to monitor airflow characteristics and / or operate system 10 in a manner that provides appropriate therapy. Airflow characteristics may include gas concentration, flow rate, pressure, temperature, humidity, or other properties. Sensors 3a, 3b, 3c, 20, 25, such as pressure, temperature, humidity, and / or flow sensors, can be placed in various locations within the main unit housing 100, the patient tubing 16, and / or the patient interface 17. Controller 13 can receive outputs from the sensors to assist it in operating respiratory system 10 in a manner that provides appropriate therapy, such as determining appropriate target temperatures, flow rates, and / or pressures of the airflow. Providing appropriate therapy may include meeting the patient's inspiratory needs. Appropriate therapeutic flow rates, such as high-flow therapeutic flow rates and / or flow rates that meet or exceed the patient's inspiratory needs, are explained below.

[0175] System 10 may include a wireless data transmitter and / or receiver or transceiver 15 to enable controller 13 to wirelessly receive data signals 8 from the operating sensors and / or control various components of system 10. Alternatively, the data transmitter and / or receiver 15 may deliver data to a remote server or enable remote control of system 10. In one example, the remote server may record patient usage data, such as usage of a bubble CPAP system or a high-flow system. Usage may include usage time and / or also include flow rate and humidity level (e.g., dew point). System 10 may also include wired connections, such as using cables or wires, to enable controller 13 to receive data signals 8 from the operating sensors and / or control various components of system 10.

[0176] System 10 can be powered by a power supply voltage.

[0177] In some embodiments, the system may include an auxiliary power source (e.g., a battery).

[0178] In some embodiments, the system may include a battery. The battery can provide primary power to the system or act as an auxiliary power source when primary power is unavailable. This is advantageous because it allows for continuous delivery of treatment, meaning that gas can be continuously delivered to the patient even if the power supply is insufficient or interrupted. This is advantageous because, for newborns or infants, treatment can be maintained for a period of time, thereby reducing the chances of physiological deterioration or harm to these patients due to loss of treatment.

[0179] Batteries can increase the portability of the system, allowing it to be used in situations where power supply is unavailable.

[0180] High-flow therapy, as discussed herein, is intended to be given the typical, common meaning as understood by those skilled in the art, and generally refers to a respiratory support system that delivers a humidified target airflow at a flow rate typically designed to meet or exceed the patient's inspiratory flow rate via an intentionally unsealed patient interface. Typical patient interfaces include, but are not limited to, nasal or tracheal patient interfaces. Typical flow rates for adults typically range from, but are not limited to, about 15 liters / minute to about 60 liters / minute or greater than 60 liters / minute. Typical flow rates for pediatric patients (such as newborns, infants, and children) typically range from, but are not limited to, about 1 liter / minute / kg of patient weight to about 3 liters / minute / kg of patient weight or greater than about 3 liters / minute / kg of patient weight. High-flow therapy may also optionally comprise a gas mixture composition containing supplemental oxygen and / or administration of therapeutic drugs. High-flow therapy is often referred to as nasal high-flow (NHF), humidified high-flow nasal cannula (HHFNC), high-flow nasal oxygen (HFNO), high-flow therapy (HFT), or tracheal high-flow (THF), among other common names.

[0181] As used herein, “high-flow” therapy can also refer to the delivery of gas to a patient’s airway at a relatively high flow rate that optionally meets or exceeds the patient’s peak inspiratory demand. Some example flow rates used to achieve “high flow” can be any of the flow rates listed below. For example, in some configurations, for adult patients, “high-flow” therapy can refer to delivering gas to the patient at a flow rate greater than or equal to about 10 liters per minute (10 LPM), such as between about 10 LPM and about 100 LPM, or between about 15 LPM and about 95 LPM, or between about 20 LPM and about 90 LPM, or between about 25 LPM and about 85 LPM, or between about 30 LPM and about 80 LPM, or between about 35 LPM and about 75 LPM, or between about 40 LPM and about 70 LPM, or between about 45 LPM and about 65 LPM, or between about 50 LPM and about 60 LPM. In some configurations, for neonatal, infant, or pediatric patients, "high-flow therapy" can refer to gas delivery to the patient at a flow rate greater than 1 LPM, such as between about 1 LPM and about 25 LPM, or between about 2 LPM and about 25 LPM, or between about 2 LPM and about 5 LPM, or between about 5 LPM and about 25 LPM, or between about 5 LPM and about 10 LPM, or between about 10 LPM and about 25 LPM, or between about 10 LPM and about 20 LPM, or between about 10 LPM and about 15 LPM, or between about 20 LPM and about 25 LPM. High-flow therapy devices for adult, neonatal, infant, or pediatric patients can deliver gas to the patient at a flow rate between about 1 LPM and about 100 LPM, or at any of the subranges outlined above.

[0182] Figure 3B and Figure 3C An example respiratory device for a respiratory system 10 is shown. The device may include a housing 300 that encloses a flow generator. The flow generator may include a motor and / or sensor module. The motor and / or sensor module may be non-removable from the main housing 300. Alternatively, the motor and / or sensor module may be removable from the main housing 300. The housing 300 may include a humidifier or humidification chamber compartment 318 for housing a removable humidification chamber 310. The removable humidification chamber 310 contains a suitable liquid, such as water, for heating and humidifying the gas delivered to the patient. The humidification chamber 310 may be linearly slid into the chamber compartment 318 to be fluidly coupled to the device housing 300. A gas outlet orifice 322 may establish fluid communication between the motor and / or sensor module and the inlet 306 of the chamber 310.

[0183] Heated and humidified gas can be discharged from outlet 308 of chamber 310 to humidified gas return section 340, which may include a removable L-shaped elbow. The removable elbow may further include a patient outlet port 344 for connection to an inspiratory tubing, such as... Figure 3A The inhalation conduit 16 delivers gas to the patient interface 17. The gas outlet port 322, humidified gas return section 340, and patient outlet port 344 may each have a seal, such as an O-ring seal or a T-seal, to provide a sealed gas passage between the device housing 300, the humidification chamber 310, and the inhalation conduit. The base plate portion of the humidification chamber compartment 318 in the housing 300 may include a heater configuration, such as a heater plate or other suitable heating element, for heating water in the humidification chamber 310 for use during the humidification process. The elbow may include one or more integrated sensors. For example, the elbow may include a pair of embedded temperature sensors.

[0184] like Figure 3C As shown, the device may include a configuration that enables a flow generator to deliver air, oxygen (or an alternative auxiliary gas), or a suitable mixture thereof to the humidification chamber 310 and thereby to the patient. This configuration may include an air inlet 356' in the rear wall 322 of the housing 300. The device may include a separate oxygen inlet orifice 358'. In the illustrated configuration, the oxygen inlet orifice 358' may be positioned adjacent to one side of the rear end of the housing 300. The oxygen orifice 358' may be connected to an oxygen source, such as a reservoir, or an oxygen mixer. The oxygen inlet orifice 358' may be in fluid communication with a valve. The valve may suitably be a solenoid valve, which enables control of the amount of oxygen added to the flow of air delivered to the humidification chamber 310.

[0185] The housing 300 may contain suitable electronic boards, such as sensing circuit boards. The electronic boards may house or communicate electrically with suitable electrical components or electronic devices, such as, but not limited to, microprocessors, capacitors, resistors, diodes, operational amplifiers, comparators, and switches. One or more sensors may be used with the electronic boards. Components of the electronic boards (such as, but not limited to, one or more microprocessors) may act as the controller 13 of the device. One or both of the electronic boards may communicate electrically with electrical components of the system 10, including, but not limited to, a display unit and user interface 14, motors, valves, and heater boards, to operate the motors to provide the desired gas flow rate, humidify and heat the gas flow to appropriate levels, and supply an appropriate amount of oxygen (or an appropriate amount of alternative auxiliary gas) to the gas flow.

[0186] As described above, operational sensors such as flow, temperature, humidity, and / or pressure sensors can be placed in various locations within the respiratory apparatus, patient tubing 16, and / or catheter 17. An electronic board can communicate electrically with those sensors. Outputs from the sensors can be received by the controller 13 to assist it in operating the respiratory system 10 in a manner that provides optimal therapy (including meeting inspiratory needs). One or more sensors (e.g., Hall effect sensors) can be used to measure the motor speed of the flow generator's motor. The motor can comprise a brushless DC motor from which motor speed can be measured without the use of separate sensors. For example, during operation of the brushless DC motor, the back EMF can be measured from the unenergized winding of the motor, from which the motor position can be determined, which can then be used to calculate the motor speed. Furthermore, a motor driver can be used to measure the motor current, which can be used together with the measured motor speed to calculate the motor torque. The motor can also comprise a low-inertia motor.

[0187] Indoor air can be transmitted through, for example, Figure 3C The air inlet orifice 356' enters the flow generator. The flow generator can operate at motor speeds greater than 1,000 RPM and less than 30,000 RPM, greater than 2,000 RPM and less than 21,000 RPM, greater than 4,000 RPM and less than 15,000 RPM, or between any of the foregoing values. The operation of the flow generator can mix the gas entering the flow generator (such as the motor and / or sensor chamber) via the inlet orifice. Using a flow generator as a mixer can reduce the pressure drop that would otherwise occur in systems with separate mixers (such as static mixers including baffles), because mixing requires energy.

[0188] like Figure 4 As shown, the mixed air can exit the flow generator and enter a flow path 402 within a sensor chamber 400, which may be located in the motor and / or sensor module. A sensing circuit board 404, having sensors such as an ultrasonic sensor 406 and / or a heated thermistor flow sensor, can be positioned within the sensor chamber 400 such that the sensing circuit board is at least partially immersed in the airflow. At least some of the sensors on the sensing circuit board can be positioned within the airflow to measure the gas properties within the flow. After passing through the flow path 402 in the sensor chamber 400, the gas can exit into a humidification chamber 310.

[0189] Compared to systems that position the sensor upstream of the flow generator and / or mixer, positioning the sensor downstream of the flow generator improves measurement accuracy, such as for measurements of gas fractional concentrations including oxygen concentration. This positioning produces repeatable flow profiles. Furthermore, positioning the sensor downstream of the combined flow generator and mixer avoids the pressure drop effect that would normally occur before sensing occurs at the flow generator and separate mixer. Moreover, immersing at least a portion of the sensing circuit board and sensor in the flow path improves measurement accuracy because a sensor immersed in the flow is more likely to experience the same conditions as the airflow, such as temperature and pressure, and thus provides a better representation of the airflow characteristics.

[0190] like Figure 4 As shown, the flow path 402 can have a curved shape. The flow path 402 can be configured to have a curved shape without sharp bends. The flow path 402 can have curved ends, with relatively straight sections between these curved ends. The curved flow path shape can reduce the pressure drop in the airflow without reducing the sensitivity of the flow measurement by partially aligning the measurement area with the flow path to form the measurement portion of the flow path.

[0191] The sensing circuit board 404 may include sensors such as acoustic transmitters and / or receivers, humidity sensors, temperature sensors, thermistors, etc. At least two different types of sensors can be used to measure gas flow rates. The first type of sensor may include a thermistor, which determines the flow rate by monitoring heat transfer between the gas flow and the thermistor. As the gas flows around and over the thermistor, the thermistor flow sensor allows the thermistor to operate at a constant target temperature within the flow. The sensor can measure the electrical charge required to maintain the thermistor at the target temperature. The target temperature can be configured to be higher than the temperature of the gas flow, requiring more power to maintain the thermistor at the target temperature at higher flow rates.

[0192] The thermistor flow rate sensor can also maintain multiple (e.g., two, three, or more than three) constant temperatures on the thermistor to avoid the difference between the target temperature and the gas flow temperature being too small or too large. Multiple different target temperatures allow the thermistor flow rate sensor to be accurate over a large gas temperature range. For example, the thermistor circuit can be configured to switch between two different target temperatures, ensuring that the gas flow temperature relative to one of the two target temperatures is always within a certain range (e.g., neither too close nor too far). The thermistor circuit can be configured to operate at a first target temperature of about 50°C to about 70°C or about 66°C. The first target temperature can be associated with a desired flow temperature range between about 0°C and about 60°C or between about 0°C and about 40°C. The thermistor circuit can be configured to operate at a second target temperature of about 90°C to about 110°C or about 100°C. The second target temperature can be associated with a desired flow temperature range between about 20°C and about 100°C or between about 30°C and about 70°C.

[0193] The controller can be configured to adjust the thermistor circuit by connecting or bypassing a resistor within the thermistor circuit to vary between at least a first target temperature and a second target temperature. The thermistor circuit can be configured as a Wheatstone bridge configuration including a first voltage divider arm and a second voltage divider arm. The thermistor can be located on one of the voltage divider arms. Further details of the thermistor flow rate sensor are described in International Patent No. WO 2018052320 A2, the entire contents of which are incorporated herein by reference.

[0194] The second type of sensor may include an acoustic (e.g., ultrasonic) sensor assembly. An acoustic sensor comprising an acoustic transmitter and / or receiver can be used to measure the time of flight of an acoustic signal, thereby determining the gas velocity and / or composition that can be used in a flow therapy device. In an ultrasonic sensing topology (comprising an ultrasonic transmitter and / or receiver), a driver causes a first sensor, such as an ultrasonic transducer, to generate an ultrasonic pulse in a first direction. A second sensor, such as a second ultrasonic transducer, receives this pulse and provides a measurement of the time of flight of the pulse between the first and second ultrasonic transducers. Using this time-of-flight measurement, the sound velocity of the airflow between the ultrasonic transducers can be calculated by a processor or controller of the respiratory device. The second sensor may also transmit in a second direction opposite to the first direction, and the first sensor may receive the pulse to provide a second measurement of the time of flight, thereby allowing the determination of airflow characteristics, such as flow rate or velocity. In another acoustic sensing topology, the acoustic pulse transmitted by an acoustic transmitter, such as an ultrasonic transducer, can be received by an acoustic receiver, such as a microphone. Further details of the acoustic flow rate sensor are described in International Patent No. WO 2017095241 A3, the entire contents of which are incorporated herein by reference. Acoustic pulses can be transmitted along the flow path of a gas, thereby allowing the use of acoustic sensors to measure the flow rate or velocity of a gas.

[0195] Readings from both the first-type and second-type sensors can be combined to determine a more accurate flow measurement. For example, a previously determined flow rate and one or more outputs from one of these types of sensors can be used to determine a predicted current flow rate. The predicted current flow rate can then be updated using one or more outputs from the other of the first-type and second-type sensors to calculate the final flow rate.

[0196] The respiratory system can be configured to deliver high-flow therapy or bubble CPAP therapy.

[0197] The breathing device can be switched between high-flow therapy mode and bubble CPAP therapy mode.

[0198] In high-flow therapy mode, the breathing device is configured to provide high-flow therapy.

[0199] In the bubble CPAP therapy mode, the breathing device is configured to provide bubble CPAP therapy.

[0200] High-flow treatment refers to nasal high-flow treatment.

[0201] In high-flow treatment mode, the system includes an unsealed patient interface connected to the inspiratory tubing 121.

[0202] An unsealed patient interface can be a nasal cannula.

[0203] During use, the nasal cannula is positioned on the user's face to deliver air to the user's nostrils.

[0204] In the bubble CPAP treatment mode, the system includes a sealed patient interface connected to the inspiratory conduit 121 and an expiratory conduit 130 connected to the sealed patient interface.

[0205] The expiratory tubing 130 is connected to a pressure regulator to adjust the pressure within the patient interface and / or the patient's airway.

[0206] As described in more detail above, the pressure regulator includes a chamber with a water column, and the exhalation tube 130 is immersed in the water column. The pressure supplied to the user is defined or set by the depth to which the exhalation tube 130 is immersed in the water column.

[0207] The inhalation tubing 121 can be shared between high-flow treatment mode and bubble CPAP treatment mode.

[0208] Using the same intake pipe for both modes reduces the number of parts that need to be interchanged when changing modes.

[0209] Furthermore, this common intake duct allows the same breathing device, including the blower and humidifier integrated into the housing, to be used for both bubble CPAP mode and high-flow mode. Additionally, integrating the humidifier and blower into a common housing simplifies switching between bubble CPAP and high-flow modes, as a single device can be used instead of a separate setup of several components as required in prior art systems.

[0210] The system of this invention provides a single breathing device that can be used to deliver both bubble CPAP therapy and high-flow therapy, with only the interface requiring modification. The components on the gas supply side remain unchanged; that is, the gas supply components are unchanged because the common breathing device can be used to deliver humidified gas.

[0211] like Figure 7 As shown, controller 13 may include a high-flow treatment control program 210 associated with the high-flow treatment mode.

[0212] like Figure 7 As shown, the controller 13 may include a bubble CPAP treatment control program 211 associated with the bubble CPAP treatment mode.

[0213] In some embodiments, the high-flow treatment mode may have a high-flow treatment controller. Optionally, the high-flow treatment controller may be configured to execute a high-flow treatment control procedure 210.

[0214] In some embodiments, the bubble CPAP therapy mode may have a bubble CPAP therapy controller. Optionally, the bubble CPAP therapy controller may be configured to execute bubble CPAP therapy control program 211.

[0215] Controller 13 is configured to select and apply programs 210, 211 corresponding to the selected operating mode.

[0216] Each definition in the high-flow-rate treatment control procedure 210 and the bubble CPAP treatment control procedure 211 corresponds to an operating parameter.

[0217] In some configurations, operating parameters may include one or more motor speed or pressure limits (e.g., pressure upper limit), as described in more detail below.

[0218] Operating parameters may include one or more alarm conditions.

[0219] One or more alarm conditions may be included in the absence of bubbling in the bubble CPAP treatment mode.

[0220] In some embodiments, an alarm can be triggered when a lack of bubbling is detected to persist for more than a certain time period.

[0221] Operating parameters can define humidity levels.

[0222] Operating parameters can be one or more temperature or dew point setpoints to control the humidifier.

[0223] The humidity level provided during high-flow mode can be greater than the humidity level provided during bubble CPAP therapy mode.

[0224] The operating parameters can also define traffic limits corresponding to each mode.

[0225] The controller can be configured to detect foaming by the bubbler, and if foaming is detected, the controller selects the bubble CPAP treatment mode.

[0226] Once the predetermined duration of bubbling has been detected, the controller can select the bubble CPAP treatment mode.

[0227] Once bubbling is detected (optionally for a predetermined amount of time), the controller can present a message to the user to consider changing the mode to bubble CPAP therapy mode.

[0228] If the bubbler is detected by bubbling, the controller can automatically switch the mode to bubble CPAP therapy mode.

[0229] Users can choose between a high-flow treatment mode or a bubble CPAP treatment mode (optionally via the user interface).

[0230] The bubbling can be detected as described elsewhere in this specification.

[0231] Controlling FdO2

[0232] As described above, a flow generator can be used as a mixer for oxygen and / or other inhalable gases. A flow generator that draws in ambient air can mix the air with oxygen from an oxygen source. This oxygen source can be a high-pressure source or a low-pressure source.

[0233] When receiving oxygen from a low-pressure source, which may include an oxygen cylinder or reservoir, an oxygen wall source, or an oxygen concentrator, the breathing apparatus can receive oxygen at a constant flow rate. This oxygen can then be mixed with ambient air. The fraction of oxygen in the gas delivered to the patient (FdO2) can depend on the set flow rate of oxygen from the low-pressure source and the total flow rate generated by the apparatus. The apparatus can measure FdO2 and display it on a display screen.

[0234] When oxygen is received from a high-pressure source, which may include an oxygen cylinder or tank, an oxygen wall-mounted source, or an oxygen concentrator, the device can control the oxygen flow rate by controlling a valve to the oxygen inlet orifice described herein. FdO2 can depend on the flow rate of oxygen through the valve (which can further depend on the valve's open state) and the total flow rate generated by the device. Users, such as clinicians, can set a target FdO2 on a user interface on a display, whereby the device then controls the valve to open based on the target FdO2 and the measured FdO2 to achieve the desired oxygen fraction. Oxygen concentration can be measured using various sensors, such as the ultrasonic sensor described above. Further details of an example method for measuring oxygen concentration are described in International Patent No. WO 2013151447 A1, the entire contents of which are incorporated herein by reference.

[0235] Control flow rate

[0236] As described above, bubble CPAP typically involves delivering a constant airflow to the patient.

[0237] In some configurations, blower and / or motor parameters can be controlled by a flow generator to maintain the flow rate at a desired level.

[0238] For example, a flow generator (or, for example, a controller) can control one or more of the motor speed, motor current, and / or motor voltage to a target motor speed, target motor current, and / or target motor voltage.

[0239] In some configurations, the breathing apparatus examples disclosed herein can measure the flow rate of the gas and control the motor speed of the flow generator, at least in part, based on the flow rate measurement, in order to maintain a constant flow rate at a desired level.

[0240] A flow generator can, for example, control the motor speed of a motor to a target motor speed. The motor speed can correspond to the desired flow rate, i.e., the target flow rate. In one example, the motor speed is a control parameter because the controller can achieve a faster response due to feedback from the motor speed being read more quickly than feedback from a sensor, such as a flow sensor downstream of a blower. Alternatively, the controller can use flow readings from a flow sensor to control the motor.

[0241] The controller directs the blower to a target motor speed or a target flow rate, or both. The controller preferably provides a control signal to control the current, voltage, or power supplied to the motor of the blower, i.e., to vary the current, voltage, or power to achieve the target motor speed or target flow rate.

[0242] As an alternative, the controller can use a combination of motor speed and flow rate to control the motor. In this example, the controller can use feedback from motor speed readings and flow rate readings from a flow sensor to control the motor to achieve a target motor speed and / or a target flow rate.

[0243] Flow rate can be measured using one or more flow rate sensors. Examples of sensors that can measure the flow rate of a gas, as described above, include ultrasonic sensors and heated thermistors. Ultrasonic sensors can provide faster signals but are generally less accurate than heated thermistors. Heated thermistors can provide more accurate signals but may not respond to small, rapid changes in flow rate. In the nasal high-flow system described herein, the flow signal from the flow sensor needs to be filtered before being used to control the flow generator. This is because patients receiving nasal high-flow may experience flow fluctuations due to coughing, talking, changing the catheter's position, etc. In such situations, it may be desirable that the device does not cause sudden changes in motor speed based on these events.

[0244] However, these patient-induced flow fluctuations are less common when delivering bubble CPAP. Therefore, flow rate control can be designed to better respond to small leaks, partial blockages, and / or dynamic changes in the patient's breathing needs within the system. Flow rate control can be achieved by using a shorter filter for flow rate measurement than in high-flow nasal therapy. Alternatively and alternatively, the controller can use flow rate measured by an ultrasonic sensor to provide a much faster signal. Alternatively and alternatively, the controller can use a combination of flow rate measurements by an ultrasonic sensor and a heated thermistor. The controller can use an ultrasonic sensor to detect higher frequency changes in flow rate and use a heated thermistor to compensate for the lower accuracy of measurements performed by the ultrasonic sensor, which may be less accurate compared to measurements performed by the heated thermistor. The controller can also use other types of sensors to measure flow rate and / or pressure. Pressure and / or flow rate sensors may comprise a single sensor.

[0245] Once the system controller receives a flow signal from one or more flow rate sensors disclosed herein, it can measure the flow rate from the flow signal. The system controller can determine the difference between the target flow rate and the measured flow rate. These differences can be input to a PID controller. The PID controller can then output a command to change the motor speed of the flow generator based on the input. In one example, the PID controller can output current, voltage, or electrical power to the motor to control its speed.

[0246] Flow rate control can also be based on pressure measurements. In conventional bubble CPAP systems, a pressure-reducing valve is placed between the flow source and the patient. This valve can be a passive valve that opens at a set pressure to release a portion of the gas flow, thereby limiting the pressure of the gas delivered to the patient.

[0247] By using a flow generator to provide airflow, pressure can be limited via software to control the motor speed of the flow generator. The high-flow system described herein may not include an additional valve for discharging excess flow. Compared to discharging gas via a pressure reducing valve, controlling the motor speed provides more accurate pressure control because the flow generator's motor speed can be directly controlled based on the measured pressure. As described herein, a breathing system (i.e., a breathing device) with a flow generator does not require a pressure reducing valve because if a pressure limit is reached, the flow generator can be controlled to reduce the motor speed to produce less pressure. The system is simplified and requires fewer components because it does not require a pressure reducing valve or a gas source.

[0248] Figure 5This is an example block diagram illustrating motor control via a device controller. The device controller can receive input 502 from one or more pressure sensors. The controller can measure the pressure delivered to the patient from the pressure sensor input. The pressure sensor can be located downstream of the flow generator. For example, the pressure sensor can be located at or near the patient interface. The pressure sensor can also be located directly after the flow generator. The pressure delivered to the patient can be determined by obtaining the difference between the ambient pressure and the absolute pressure downstream of the flow generator. The pressure delivered to the patient can be estimated by measuring the pressure in the main device housing downstream of the flow generator and calculating the pressure drop along the inhalation duct. The pressure sensor can also be located at other points in the airflow. The pressure measurement can also optionally be calculated at least in part based on the flow rate. The pressure sensor can include one gauge pressure sensor, or alternatively two absolute pressure sensors. The gauge pressure sensor can directly measure the difference between the absolute pressure downstream of the flow generator and the ambient pressure. In a system with two absolute pressure sensors, one sensor can be located downstream of the flow generator to measure the absolute pressure downstream of the flow generator, and the other sensor can be located at a different point to measure the ambient pressure. The controller can determine the pressure delivered to the patient by determining the difference between the pressure measurements taken by the two absolute pressure sensors.

[0249] At decision logic 504, the controller can compare the measured pressure (e.g., as described above) with a predetermined pressure limit. The pressure limit can be set to a pressure higher than the maximum pressure that the bubbler can be set to. In some configurations, the bubbler can be set to a maximum pressure of about 10 cmH2O, and the pressure limit for pressure control can be set to, for example, about 12 cmH2O, about 13 cmH2O, about 14 cmH2O, about 15 cmH2O, about 16 cmH2O, about 17 cmH2O, or about 18 cmH2O.

[0250] Stress limits can be based on environmental stress.

[0251] The relationship between pressure limits can be linear or non-linear.

[0252] Pressure limits can be based on a fixed amount or percentage above ambient pressure.

[0253] Pressure limits are based on ambient pressure and allow for compensation of ambient pressure. This can be important in bubble CPAP systems because the maximum pressure of the bubbler will be affected by ambient pressure, and therefore the effect of ambient pressure can be incorporated into the determination of pressure limits.

[0254] In some embodiments, the pressure limit may be based on a predetermined environmental pressure (e.g., a preset non-measuring environmental pressure).

[0255] Pressure limits can be set by the user.

[0256] If the measured pressure is below a limit, the controller can adjust the motor speed based on the output of the flow-based PID controller 506 described herein. The controller can input the difference between a target or set flow rate (such as one set by the user) and the measured flow rate into the PID controller. The controller can output the motor speed determined by the PID controller as output 510, the PID controller being configured to maintain the target flow rate.

[0257] If the measured pressure exceeds the pressure limit, the controller can implement a pressure limit algorithm 508. The pressure limit algorithm 508 can reduce the target motor speed based on a setpoint, a set reduction rate, a variable reduction rate, or by using pressure-based PID control. The controller can output the reduced motor speed as control output 510. Figure 5 As shown, in each iteration of motor control, the target motor speed is reduced until the measured pressure is below the pressure limit. The target motor speed can be reduced at a constant rate or a variable rate.

[0258] In some embodiments, the pressure limit algorithm 508 may reduce the target motor speed proportionally to the amount by which the measured pressure exceeds the pressure limit (e.g., as part of proportional control).

[0259] In some embodiments, the pressure limit algorithm 508 may reduce the target motor speed to reduce the measured pressure below a pressure limit within a predetermined time period. For example, the pressure limit algorithm 508 may reduce the target motor speed such that the measured pressure falls below the pressure limit within about 2 to about 20 seconds, or about 5 to about 15 seconds, or about 10 seconds.

[0260] In some embodiments, the target motor speed reduction rate can be set high enough to reduce the measured pressure below the pressure within a predetermined time.

[0261] Additionally and / or alternatively, the device may output visual, auditory, and / or tactile alarms when the measured pressure exceeds a threshold.

[0262] In some configurations, the device can prevent the motor from exceeding a set speed to further prevent excessive pressure from being delivered to the patient. Motor speed limiting can act as a fail-safe measure in cases where one or more sensors output erroneous pressure measurements and / or otherwise malfunction. That is, two checks can be used to prevent the airflow pressure from exceeding a predetermined maximum value. One check could be a pressure limit. In cases of erroneous pressure sensor readings, another check could be a maximum motor speed limit.

[0263] In some embodiments, the motor speed limit can be variable.

[0264] Motor speed limits can be based on environmental pressures. This allows, for example, motor speed limits to take into account the height of the device.

[0265] The relationship between motor speed limits and environmental pressure can be linear or nonlinear.

[0266] In some embodiments, when the ambient pressure is a first ambient pressure (e.g., about 101 kPa (i.e., about sea level)), the motor speed limit may be a first motor speed (e.g., 10,000 RPM).

[0267] In some embodiments, when the ambient pressure is a second ambient pressure (e.g., about 79.5 kPa (i.e., about 2000 meters above sea level) or, for example, about 70.1 kPa (i.e., about 3000 meters above sea level)), the motor speed limit may be a second motor speed (e.g., about 15,000 RPM).

[0268] Between the first and second environmental pressures, the motor speed limit can vary between the first and second motor speeds.

[0269] In some embodiments, motor speed limits may be further based on ambient temperature.

[0270] Detecting bubbles

[0271] The flow generator of a high-flow-rate device can also be configured to detect the presence of bubbles in the bubbler. Bubbling can be used to indicate that the system is operating correctly. For example, a temporary lack of bubbles can indicate that the patient's peak inspiratory flow exceeds the flow rate delivered by the device at that moment. Conversely, a prolonged lack of bubbles can indicate a leak in the gas path, such as in the ventilation circuitry.

[0272] Foaming can be detected by detecting oscillations in pressure and / or flow rate. In breathing systems where the flow rate is controlled by a device controller, the controller can use a pressure signal input, such as from a pressure sensor disclosed herein, to determine the presence of foaming.

[0273] Figure 6 This illustrates an example flowchart used to determine whether bubbling is detectable. Although the pressure signal is used... Figure 6The flowchart is an example, but it can also be applied to combinations of flow signals and / or pressure signals with flow signals. At step 602, the controller can receive a pressure signal from a pressure sensor. At step 603, the pressure signal can optionally be filtered such that the measured amplitude is the amplitude of the measured pressure signal. At step 604, the controller can determine the variation in the pressure signal from the mean of the pressure of the airflow delivered to the patient (e.g., measured by one or more pressure sensors disclosed herein). At steps 606 and 608, the controller can determine whether an oscillation exists in the pressure signal. An oscillation exists if the variation exceeds a specific amplitude (606) and is above a specific frequency (608). For example, a high-pass filter with a cutoff frequency of about 5 Hz or a band-pass filter with cutoff frequencies of about 5 Hz and about 20 Hz can be used to filter the pressure signal. The specific amplitude (e.g., when measured between peaks) can be about 0.25 cmH2O. The threshold amplitude can be a single threshold or can vary depending on the set flow rate or pressure. If this oscillation exists, the controller can output an indication that foaming has occurred at step 610. In the example provided herein, if an oscillation with an amplitude (e.g., when measured between peaks) greater than approximately 0.25 cmH2O exists in the filtered signal, the controller can determine that bubbling has been detected. If the amplitude does not exceed approximately 0.25 cmH2O, the controller can determine that bubbling cannot be detected. Alternatively, the controller can analyze the power spectrum in the frequency domain. If sufficient power exists in the frequency band, the controller can determine that bubbling has been detected. Otherwise, the controller can determine that bubbling has not been detected. The controller can then return to step 602. At step 606, if the change does not exceed the amplitude limit, and / or at step 608, if the change does not exceed the frequency limit, the controller can return to step 602 to repeat the bubbling detection procedure. The controller can optionally output a visual, audio, and / or tactile alarm indicating the absence of bubbling at steps 612 and 614.

[0274] The controller can also optionally monitor the duration for which bubbling is considered absent. If no bubbling is detected within a predetermined duration (such as about 5 seconds, about 10 seconds, about 15 seconds, about 20 seconds, or longer), the controller can optionally output a message prompting the user to check for leaks in the gas path of the respiratory system.

[0275] the term

[0276] Although this disclosure has been described in the context of certain embodiments and examples, those skilled in the art will understand that this disclosure extends beyond the specific disclosed embodiments to other alternative embodiments and / or uses, as well as obvious modifications and their equivalents. Furthermore, while several variations of the embodiments of this disclosure have been shown and described in detail, other modifications within the scope of this disclosure will be apparent to those skilled in the art. Various combinations or sub-combinations of specific features and aspects of the embodiments are also contemplated and remain within the scope of this disclosure. For example, a feature described above in conjunction with one embodiment may be used with different embodiments described herein, and the combination remains within the scope of this disclosure. It should be understood that various features and aspects of the disclosed embodiments may be combined or substituted with each other to form variations of the embodiments of this disclosure. Therefore, it is expected that the scope of this disclosure will not be limited to the specific embodiments described above. Thus, unless otherwise stated or unless obviously incompatible, each embodiment of the invention may include one or more features as described herein from each other embodiment of the invention disclosed herein, in addition to the essential features described herein.

[0277] Features, materials, characteristics, or groups described in connection with a particular aspect, embodiment, or example should be understood to be applicable to any other aspect, embodiment, or example described elsewhere in this section or specification, unless incompatible therewith. All features disclosed in this specification (including any appended claims, abstracts, and drawings) and / or all steps of any method or procedure so disclosed may be combined in any combination, except for at least some mutually exclusive combinations of such features and / or steps. The scope of protection is not limited to the details of any of the foregoing embodiments. The scope of protection extends to any novel feature or any novel combination of features disclosed in this specification (including any appended claims, abstracts, and drawings), or to any novel step or any novel combination of steps in any method or procedure so disclosed.

[0278] Furthermore, some features described in this disclosure within the context of separate implementations can also be implemented in combination in a single implementation. Conversely, the various features described in the context of a single implementation can also be implemented separately or in any suitable sub-combination in multiple implementations. Moreover, although features may be described above as functioning in certain combinations, one or more features from a claimed combination may be removed from that combination under certain circumstances, and that combination may be claimed as a sub-combination or a variation of a sub-combination.

[0279] Furthermore, while operations may be depicted in a specific order in the accompanying drawings or described in the specification, such operations need not be performed in the specific order shown or in sequential order, or all operations need not be performed to achieve the desired result. Other operations not depicted or described may be incorporated into the example methods and procedures. For example, one or more additional operations may be performed before, after, simultaneously with, or between any of the described operations. Additionally, operations may be reconfigured or reordered in other implementations. Those skilled in the art will understand that in some embodiments, the actual steps taken in the illustrated and / or disclosed procedures may differ from those shown in the figures. Depending on the embodiment, some steps described above may be removed, and other steps may be added. Furthermore, features and properties of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of this disclosure. Moreover, the separation of the various system components in the implementations described above should not be construed as requiring such separation in all implementations, and it should be understood that the described components and systems can generally be integrated together in a single product or packaged into multiple products.

[0280] For the purposes of this disclosure, certain aspects, advantages, and novel features are described herein. Not all such advantages may be achieved according to any particular embodiment. Therefore, for example, those skilled in the art will recognize that the present disclosure may be embodied or carried out in ways that achieve one or a set of advantages as taught herein but not necessarily other advantages as taught or suggested herein.

[0281] Unless otherwise specifically stated or otherwise understood as used in the context, the conditional language used herein, such as “can,” “may,” “perhaps,” “may,” “can,” “for example,” etc., is generally intended to convey that some embodiments include certain features, components, and / or steps, while other embodiments do not include certain features, components, and / or steps. Therefore, this conditional language is not generally intended to imply that features, components, and / or steps are required in any one or more embodiments, or that one or more embodiments must include logic for determining whether such features, components, and / or steps are included or to be performed in any particular embodiment, with or without additional input or prompts. The terms “comprising,” “including,” “having,” etc., are synonymous and used inclusively in an open-ended manner, and do not exclude additional components, features, actions, operations, etc. Furthermore, the term “or” is used in its inclusive meaning (and not its exclusive meaning) such that when used, for example, to connect a list of elements, the term “or” refers to one, some, or all of the elements in the list.

[0282] Unless otherwise specifically stated, connective language such as the phrase “at least one of X, Y, and Z” should be understood, as in the context in which it is used, to generally convey that an item, term, etc., may be X, Y, or Z. Therefore, this connective language is not generally intended to imply that some embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.

[0283] The degree language used herein, such as the terms “approximately,” “about,” “generally,” and “substantially,” means that a value, quantity, or characteristic close to the stated value, quantity, or characteristic still performs the desired function or achieves the desired result. For example, the terms “approximately,” “about,” “generally,” and “substantially” can refer to a quantity within 10%, 5%, 1%, 0.1%, and 0.01% of the stated quantity. As another example, in some embodiments, the terms “generally parallel” and “substantially parallel” refer to a value, quantity, or characteristic that deviates from perfect parallelism by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, 0.1 degrees, or other values, quantities, or characteristics.

[0284] No method disclosed herein needs to be performed in the order described. The methods disclosed herein include certain actions performed by a physician; however, these methods may also explicitly or implicitly include any third-party instructions regarding those actions. For example, an action such as “controlling the motor speed” includes “instructing to control the motor speed”.

[0285] All methods and tasks described herein can be performed by a computer system and are fully automated. In some cases, a computer system may include multiple different computers or computing devices (e.g., physical servers, workstations, storage arrays, cloud computing resources, etc.) that communicate and interact via a network to perform the described functions. Each computing device typically includes a processor (or multiple processors) that executes program instructions or modules stored in memory or other non-transitory computer-readable storage media or devices (e.g., solid-state storage devices, disk drives, etc.). The various functions disclosed herein may be embodied in such program instructions and / or may be implemented in special application circuitry systems (e.g., ASICs or FPGAs) of the computer system. In cases where a computer system includes multiple computing devices, these devices may be co-located, but are not required to be. The results of the disclosed methods and tasks can be continuously stored by changing the physical storage devices (such as solid-state memory chips and / or disks) into different states. In some embodiments, the computer system may be a cloud-based computing system whose processing resources are shared by multiple different business entities or other users.

[0286] The scope of this disclosure is not intended to be limited by the specific disclosures of preferred embodiments in this section or elsewhere in this specification, and may be defined by the claims as presented in this section or elsewhere in this specification or as presented in the future. The language of the claims should be interpreted broadly based on the language used in the claims and is not limited to the examples described in this specification or during the examination of this application, which should be construed as non-exclusive.

Claims

1. A respiratory system configured to deliver high-flow therapy or bubble CPAP therapy, wherein, The respiratory system includes: Breathing device, which includes a flow generator, The humidifier is in fluid communication with the flow generator. The controller is configured to control the flow generator. The air intake pipe is in fluid communication with the humidifier, and The breathing device can switch between high-flow therapy mode and bubble CPAP therapy mode. In the high-flow treatment mode, the breathing device is configured to provide high-flow treatment; and in the bubble CPAP treatment mode, the breathing device is configured to provide bubble CPAP treatment. Users can choose between the high-flow treatment mode or the bubble CPAP treatment mode.

2. The respiratory system according to claim 1, wherein, The high-flow treatment mentioned is nasal high-flow treatment.

3. The respiratory system of claim 1, wherein in the high-flow treatment mode, the system includes an unsealed patient interface coupled to the inspiratory tubing.

4. The respiratory system according to claim 3, wherein, The unsealed patient interface is a nasal cannula.

5. The respiratory system according to claim 4, wherein, The nasal cannula is positioned on the user's face to deliver air into the user's nostrils.

6. The respiratory system according to claim 1, wherein, In the bubble CPAP treatment mode, the system includes a sealed patient interface connected to the inhalation tubing and an expiratory tubing connected to the sealed patient interface.

7. The respiratory system of claim 6, wherein the expiratory conduit is connected to a pressure regulator to regulate the pressure within the patient interface and / or the patient's airway.

8. The respiratory system of claim 7, wherein the pressure regulator includes a chamber having a water column, wherein the expiratory conduit is immersed in the water column.

9. The respiratory system according to claim 8, wherein, The pressure supplied to the user is limited or set by the immersion depth of the exhalation tube within the water column.

10. The respiratory system according to claim 8, wherein, The controller is configured to detect bubbling in the pressure regulator.

11. The respiratory system according to claim 10, wherein, If the controller detects bubbling, it selects or switches to the bubble CPAP treatment mode.

12. The respiratory system according to claim 10, wherein, If the controller detects bubbling, it automatically switches modes.

13. The respiratory system according to claim 10, wherein, The controller is configured to detect bubbling by monitoring changes in flow parameter signals.

14. The respiratory system according to claim 13, wherein, The flow parameter signals include flow rate signals, pressure signals, or combinations thereof.

15. The respiratory system according to claim 13, wherein, The change in the flow parameter signal is the change in the amplitude of the flow parameter signal relative to a threshold.

16. The respiratory system according to claim 13, wherein, The changes in the flow parameter signal are analyzed in the frequency domain.

17. The respiratory system according to any one of claims 1 to 16, wherein, The breathing device includes a housing, wherein the flow generator and the humidifier are integrated into the housing.

18. The respiratory system according to claim 17, wherein, The controller is located inside the housing.

19. The respiratory system according to claim 17, wherein, The humidifier includes a heater plate and / or a humidification chamber.

20. The respiratory system according to claim 19, wherein, The heater plate is positioned inside the housing.

21. The respiratory system according to claim 19, wherein, The heater plate is located in the chamber compartment.

22. The respiratory system according to any one of claims 19, wherein the humidification chamber is removably positioned on the heater plate.

23. The respiratory system of claim 17, wherein the housing includes a gas outlet and the inhalation conduit is connectable to the outlet.

24. The respiratory system according to claim 1, wherein, The inhalation tubing can be used for both the high-flow treatment mode and the bubble CPAP treatment mode.

25. The respiratory system according to claim 1, wherein, The controller includes a high-flow treatment control program associated with the high-flow treatment mode.

26. The respiratory system according to claim 1, wherein, The controller includes a bubble CPAP treatment control program associated with the bubble CPAP treatment mode.

27. The respiratory system according to claim 25 or 26, wherein, The controller is configured to select and apply a program corresponding to the selected operating mode.

28. The respiratory system according to any one of claims 25 or 26, wherein, The high-flow treatment control program and / or the bubble CPAP treatment control program define the operating parameters.

29. The respiratory system according to claim 28, wherein, The operating parameters include at least one of the following: One or more motor speed or pressure limits, One or more alarm conditions, One or more temperature setpoints, One or more traffic limits.

30. The respiratory system according to claim 28, wherein, The operating parameters include one or more humidity parameters that define the humidity level.

31. The respiratory system according to claim 30, wherein, The humidity level provided during the high-flow treatment mode can be greater than the humidity level provided during the bubble CPAP treatment mode.

32. The respiratory system according to any one of claims 1 to 16, wherein, A high-flow treatment mode kit for use with a breathing device includes one or more of the following: a non-sealed patient interface, an inspiratory tubing, and the inspiratory tubing.

33. The respiratory system according to claim 32, wherein, The high-flow treatment mode kit is used in the high-flow treatment mode.

34. The respiratory system according to any one of claims 1 to 16, wherein, A bubble CPAP therapy mode kit for use with a breathing device includes one or more of the following: a sealed patient interface, an inspiratory conduit, an expiratory conduit, and / or a pressure regulator.

35. The respiratory system according to claim 34, wherein, The bubble CPAP treatment mode kit is used for the bubble CPAP treatment mode.

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